23andMe markets The Saliva Collection Kit and Personal Genome Service (PGS) to determine if customers carry a disease and whether they would respond to a drug. These kits are also the first to check for 240 DNA-linked diseases and conditions. Since there are various categories, the kit is considered a medical device and therefore is subject to FDA approval under the Federal Food, Drug, and Cosmetic Act.

While the company hoped to clear up the FDA mess, and thus renew their marketing efforts, the news was like blood in the water, and shark-like lawyers immediately launched a 23andMe lawsuit. One of these sharks is named Mark Ankcorn, a San Diego attorney who filed the lawsuit on behalf of local resident Lisa Casey:

“They are making specific claims in the market place that are not backed up by science. We’d like to make them stop making these claims and stop selling these tests. They need to be upfront with the American people.”

The 23andMe lawsuit alleges the DNA test results are “meaningless” and claims “tens or hundreds of thousands” of Americans are entitled to damages of at least $5 million. The lawyer for Casey also believes 23andMe is using the test results to build a DNA database that can be mined for information used in medical research.

“23andMe was started in 2007 with the belief that consumers have the right to get access to their genetic information and that information can help them live healthier lives. It is absolutely critical that our consumers get high quality genetic data that they can trust. We have worked extensively with our lab partner to make sure that the results we return are accurate. We stand behind the data that we return to customers — but we recognize that the FDA needs to be convinced of the quality of our data as well.”

Do you think the 23andMe lawsuit is justified or just another frivolous attempt by lawyers to suck money out of companies?